Feasibility and Acceptability of Wearable Sensors and ePROs in Early Phase Clinical Trials

Wearable sensors offer opportunities to improve the people's experiences with cancer treatment and to improve care delivery. This is a single-arm, prospective, unblinded pilot study designed to evaluate the feasibility and acceptability of wearable sensor-based monitoring and incorporating electronic patient-reported outcomes (ePROs) in Phase I oncology clinical trials. The study will enroll participants enrolled in early phase clinical trials at the Cleveland Clinic Novel Therapeutics Clinic and aims to establish the foundation for future, larger-scale prospective studies integrating digital health technologies into early-phase cancer clinical trials. Participants will be offered a smartwatch device compatible to their phone's operating system and be guided through the installation and use of the researchers' free study mobile application. Participants already owning compatible smartwatch devices may elect to use their own smartwatch for the study.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer
• Intervention / Treatment: Device: Wearable actigraphy; Other: Electronic Patient-Reported Outcomes (ePROs)

Detailed Description

In oncology, clinicians and researchers look at a person's clinical condition and functional status to understand how cancer and its treatment affect them. They use standardized rating scales to measure side effects from the disease or treatment. These scales grade how severe symptoms are based on factors such as the need for medical care, hospital stays, and whether a person can carry out daily activities.

Standard grading systems are commonly used in oncology to measure treatment- and disease-related side effects. These systems assign levels of severity based on clinical criteria, such as whether a person needs medical treatment, hospitalization, or has trouble with daily activities. These methods work well for measuring objective side effects, such as low blood cell counts or high liver enzyme levels. However, they are less accurate for symptoms that depend on a person's personal experience, such as fatigue, pain, or general discomfort. In these cases, there can be a gap between what people feel and what clinicians record. Because these symptoms depend on individual perception, they may be underreported or remembered inaccurately, which can make it harder for clinician reports to fully capture the person's symptom burden.

Most clinical trials, including large phase III randomized studies, use functional assessment scales to estimate how active participants are and how well they can tolerate treatment. Common tools include the Karnofsky Performance Status (KPS) and the Eastern Cooperative Oncology Group (ECOG) Performance Status. These scales are widely used in both research and clinical care to estimate prognosis, measure functional ability, and decide whether people are eligible for clinical trials. Although these scales are generally consistent, they do not always match closely with patient-reported outcomes or quality-of-life measures. Agreement between clinicians is usually good when people are grouped into broad categories (such as ECOG 0-2 versus 3-4). However, reliability decreases when clinicians try to distinguish between more specific categories, such as ECOG 0, 1, or 2.

Because of these limitations in measuring treatment tolerability, data often show differences in how well people tolerate treatment. This highlights the need for more objective and person-centered ways to measure functional status and symptoms. Wearable activity monitors may help address this issue by collecting continuous, real-time data about a person's physical activity and physiology. These devices may provide a clearer picture of how a person's function changes during treatment. When combined with electronic patient-reported outcomes (ePROs), wearable technology could improve symptom monitoring, help classify people more accurately, and support better treatment decisions in early-phase oncology trials.

Although earlier studies have shown that wearable devices can be used to monitor functional status in people with advanced gastrointestinal and lung cancers, their use in early-phase clinical trials is still limited. This study aims to address that gap by evaluating digital monitoring across several early-phase clinical trials, focusing on whether the approach is feasible rather than on disease-specific outcomes. By combining wearable activity data with ePROs, we hope to improve early detection of treatment-related side effects, refine dose-limiting toxicity (DLT) assessments, and support more accurate estimation of the maximum tolerated dose (MTD). Ultimately, this approach may help improve person-centered decision-making in early cancer drug development and guide future studies.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joel Saltzman, MD; Phone Number: 440-312-4569; Email: saltzmj@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute
      • Principal Investigator: Joel Saltzman, MD
      • Contact: Joel Saltzman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 years at the time of enrollment
• Access to a mobile phone running iOS (X or more recent) or Android 14 (or more recent)
• Ability to connect their mobile phone with their existing or provided smartwatch
• Ability to read and understand English
• Referred to the Novel Therapeutics Clinic and enrolled in an early-phase clinical trial
• Ability to demonstrate the use of a mobile device and application for electronic patient-reported outcome (ePRO) completion
• Willingness to wear an actigraphy device for 4 weeks, at least 12 hours per day over four weeks.
• Ability to provide informed consent.

Exclusion Criteria:

• Upper limb amputation, extensive tattoos, or lymphedema that may interfere with actigraphy data collection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Wearable Actigraphy + ePROs; Participants will wear an actigraphy and complete electronic patient-reported outcomes (ePROs) questionnaires on a mobile application (app) called OncoJourney for 4 weeks.

Device: Wearable actigraphy; Participants will wear an actigraphy for 4 weeks. Participants who already use a smartwatch may opt to utilize their smartwatch for actigraphy monitoring during the study period (4 weeks) instead.; Other: Electronic Patient-Reported Outcomes (ePROs); Participants will complete a weekly ePRO questionnaire on the mobile application (app) called OncoJourney. The 26-item questionnaire will ask about symptom burden for the previous 7 days. Questions will be answered on a 5-point Likert scale. Higher scores indicate greater symptoms. Participants will complete one questionnaire per week for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of integrating wearable actigraphy monitoring in early phase oncology clinical trials, as measured by proportion of participants	Feasibility of integrating wearable actigraphy monitoring is defined by the proportion of participants who wear the device for a median of at least 12 hours per day per week over 4 weeks.	4 weeks
Feasibility of integrating electronic patient-reported outcomes (ePROs) in early phase oncology clinical trials, , as measured by proportion of participants	Feasibility of integrating electronic patient-reported outcomes (ePROs) is defined by the proportion of participants who complete at least 80% of scheduled ePRO assessments over 4 weeks.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in clinician-reported and participant-reported symptoms, as measured by the ePRO-CTCAE	Symptoms will be measured by the ePRO-CTCAE questionnaire (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) tailored to participants in early phase oncology clinical trials. The ePRO-CTCAE has 26 questions regarding the presence of various symptoms answered on a 5-point Likert scale. Each question ask participants to rank the symptoms for severity from 0 (None) to 5 (Very severe), presence from 0 (Not at all) to 5 (Very much), and frequency from 0 (Never) to 5 (Almost constantly). Higher scores indicate greater symptoms.	4 weeks
Difference in time (days) from study enrollment to first occurrence of a Grade ≥1 adverse event, as based on clinician-reported CTCAE versus participant-reported ePRO-CTCAE.	Difference in time (in days) from study enrollment to first occurrence of a Grade ≥1 adverse event, as based on clinician-reported CTCAE versus weekly ePRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) tailored to participants in early phase oncology clinical trials. The ePRO-CTCAE has 26 questions regarding the presence of various symptoms answered on a 5-point Likert scale. Each question ask participants to rank the symptoms for severity from 0 (None) to 5 (Very severe), presence from 0 (Not at all) to 5 (Very much), and frequency from 0 (Never) to 5 (Almost constantly). Higher scores indicate greater symptoms.	4 weeks
Qualitative experience of the participants with respect to usability of the mobile app and wearable device during the study	Qualitative experience will be measured through exit interviews at the end of study participation and will be thematically analyzed. Interviews are semi-structured and ask questions regarding overall experience, wearable device use, app/ePRO use, adherence and engagement, perceptions of monitoring, perceived value, and suggestions for improvement.	4 weeks

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Joel Saltzman, MD, Case Comprehensive Cancer Center, Cleveland Clinic

Publications and helpful links

General Publications

• Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
• Beg MS, Gupta A, Stewart T, Rethorst CD. Promise of Wearable Physical Activity Monitors in Oncology Practice. J Oncol Pract. 2017 Feb;13(2):82-89. doi: 10.1200/JOP.2016.016857.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: April 6, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Actigraphy; Wearable; Phase 1 Clinical Trials
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CASE14Z25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No